PsychosisPhase 3NCT00281320

Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

A Phase 3 study testing Asenapine in people with Psychosis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Psychosis
What is being tested?: Asenapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: No sites listed yet
Study dates: Feb 2006to Dec 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Elderly subjects with psychosis

Who cannot join

Have an uncontrolled, unstable clinically significant
medical condition.
Have an established diagnosis of dementia

About this study

Official title: A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Conditions: Psychosis
Being tested: Asenapine
Medical subject headings: Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AsenapineDrug
Also called Saphris
Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).

Study groups in NCT00281320
Study group	Role	What they receive
Asenapine 2-10 mg BID	Experimental	Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) Receives: Drug: Asenapine
Asenapine 5-10mg BID	Experimental	Dose titration from 5 mg to 10 mg BID Receives: Drug: Asenapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event
Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).
Measured: Up to Day 42 (treatment period)
Number of Participants Who Discontinued Because of an Adverse Event
Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).
Measured: up to 30 days after study medication stop date
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
Tmax defined as time to peak concentration.
Measured: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
Cmax defined as peak concentration.
Measured: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
dn-Cmax is defined as dose normalized peak concentration.
Measured: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
Cmin defined as pre-dose concentration.
Measured: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
Measured: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.
Measured: Day 4 or 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Dec 2008

First posted24 Jan 2006 (estimated)
Study startFeb 2006
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsychosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00281320
Sponsor's protocol ID: P05717
Other IDs: A7501021
Status last verified: Feb 2022
First submitted: 23 Jan 2006
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.
PubMed 21755540

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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ACP-204 in Adults With Alzheimer's Disease Psychosis
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All Psychosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
ClinicalTrials.gov ID: NCT00281320
Acronym / sponsor ID: P05717
Conditions: Psychosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 24 Jan 2006 (estimated)
Results: Posted 9 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Asenapine 2-10 mg BID	Experimental	Drug: AsenapineDose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
Asenapine 5-10mg BID	Experimental	Drug: AsenapineDose titration from 5 mg to 10 mg BID

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

Elderly subjects with psychosis

Key exclusion criteria (3 listed)

Have an uncontrolled, unstable clinically significant
medical condition.
Have an established diagnosis of dementia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AsenapineAlso: SaphrisAsenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).	Drug	Asenapine 2-10 mg BID, Asenapine 5-10mg BID

Primary outcome

Number of Participants Who Experienced an Adverse Event
Time frame: Up to Day 42 (treatment period)
Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).
Number of Participants Who Discontinued Because of an Adverse Event
Time frame: up to 30 days after study medication stop date
Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
Time frame: Day 4 or 8
Tmax defined as time to peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
Time frame: Day 4 or 8
Cmax defined as peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
Time frame: Day 4 or 8
dn-Cmax is defined as dose normalized peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
Time frame: Day 4 or 8
Cmin defined as pre-dose concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
Time frame: Day 4 or 8
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
Time frame: Day 4 or 8
dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.

Results and safety

Results posted to the registry on 9 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asenapine 2-10 mg Twice Daily (BID)	61	36
Asenapine 5-10 mg BID	61	40

Primary outcome: Number of Participants Who Experienced an Adverse Event

Time frame: Up to Day 42 (treatment period). Number. Unit: Participants

Measure	Asenapine 2-10 mg Twice Daily (BID) n = 61	Asenapine 5-10 mg BID n = 61
Value	44	44

Population analysed: Per protocol

Primary outcome: Number of Participants Who Discontinued Because of an Adverse Event

Time frame: up to 30 days after study medication stop date. Number. Unit: participants

Measure	Asenapine 2-10 mg Twice Daily (BID) n = 61	Asenapine 5-10 mg BID n = 61
Value	12	9

Population analysed: Per protocol

Primary outcome: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax

Time frame: Day 4 or 8. Median (Full Range). Unit: hours

Measure	Asenapine 5mg BID Day 4 n = 87	Asenapine 10mg BID Day 8 n = 60
Value	1.00 (0.417 to 4.23)	1.06 (0.417 to 4.08)

Population analysed: All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.

Primary outcome: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax

Time frame: Day 4 or 8. Mean (Standard Deviation). Unit: ng/mL

Measure	Asenapine 5mg BID Day 4 n = 87	Asenapine 10mg BID Day 8 n = 60
Value	6.01 (3.89)	10.3 (6.71)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asenapine 2-10mg BID	6 of 61 (9.8%)	21 of 61 (34.4%)	Not reported
Asenapine 5-10mg BID	3 of 61 (4.9%)	21 of 61 (34.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21755540Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.

Related trials for Psychosis

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asenapine in people with Psychosis, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced an Adverse Event (time frame: Up to Day 42 (treatment period)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.